Rock sauce cream

Active ingredients

Methyl Salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical Analgesic

Uses:

For temporary relief minor muscular discomfort

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

Directions:

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

When using this product

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult a doctor and discontinus use.

if conditions persist for more than 1 week or reocur.

Inactive ingredients:

Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, propylene glycol, cetyl alcohol, dimethyl sulfoxide, poloxamer 407, capsaicin, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, boswelia serrata extract, soya lecithin, methylparaben, propylparaben, DMDM hydantoin, sodium stearoyl glutamate, triethanolamine.

Ingredients and appearance - Product information

Rock sauce cream- Methyl salicylate, menthol and capsaicin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 40104-198
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Methyl salicylate ( UNII: LAV5U5022Y)( Salicylic acid - UNII: O414PZ4LPZ ) 0.02 gin 0.1 g
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 0.01 gin 0.1 g
Capsaicin ( UNII: S07O44R1ZM)( Capsaicin - UNII: S07O44R1ZM ) 0.000002 gin 0.1 g

Inactive Ingredients

Ingredient Name Code
Carbomer 934 ( UNII: Z135WT9208)
Isopropyl alcohol ( UNII: ND2M416302)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd.( 529047265)

Establishment

Name ID/FEI Business Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd. 529047265 manufacture( 40104-198)

Principal display panel